Manager - Regulatory Affairs (Artwork Management) job opportunity at ClinChoice.

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ClinChoice Manager - Regulatory Affairs (Artwork Management)
Experience: 10-years
Pattern: full-time
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Regulatory Affairs

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loacation Bengaluru,, India
loacation Bengaluru,....India

Role Summary The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision. Key Responsibilities: • Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. Drive process improvements related to artwork development, approval workflows, and digital tools. Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. Maintain artwork issue logs and attend escalation meetings to provide updates. Identify inefficiencies and escalate to Hub Leads when required.  Participate in content lock meetings to ensure stakeholder alignment. Manage Veraciti system-related issues and escalate appropriately. Suggest and implement technology solutions for artwork and labeling processes. Create, update, and maintain training documentation for systems and processes. Supervise Artwork Controllers to ensure task completion and provide support during peak periods. Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. Track and follow up on action items from cross-functional meetings. Communicate project status, risks, and milestones consistently to stakeholders. Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. Gather requirements for new regional jobs and assess resources requirements and provide job quotations when requied. Conduct design-to-press color management assessments and feasibility consultations. Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. Address process and executional quality issues; support system and process improvements. Manage ad-hoc artwork-related requests and cascade process/system communications. Qualifications & Experience:  Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. Strong knowledge of global regulatory requirements for product labeling and packaging. Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. Six Sigma Green Belt certification or equivalent experience in continuous improvement. Excellent communication, problem-solving, and organizational skills. PMP certification or formal project management training is a plus.

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